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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Sort By 522 Order Number 522
Order
Number		 Sort By 522 Order Number -- Descending
Sort By Manufacturer Manufacturer Sort By Manufacturer -- Descending
   Sort By Device Name Device
Name		 Sort By Device Name -- Descending
Medical
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Sort By Date 522 Order Date 522
Order		 Sort By Date 522 Order -- Descending
Study
Name
Study Status
PS210001 Abbott Diabetes Care Inc. Freestyle libre 2 flash glucose monitoring system Clinical Chemistry 02/18/2021 Postmarket Surveillance Delayed
PS140001 Argo Medical Technologies, Inc Rewalk Neurology 06/26/2014 ReWalk Registry Redesigned/Replaced Study
PS200001 Avenu Medical, Inc. Ellipsys vascular access system Cardiovascular 01/10/2020 Ellipsys Vascular Access System PS Study Delayed
PS160001 Bayer Healthcare, LLC Essure system for permanent birth control Obstetrics/
Gynecology		 02/29/2016 Postmarket Surveillance Study Progress Inadequate
PS200005 Caldera Medical, Inc. Desara One Single Incision Sling System Gastroenterology/
Urology		 02/11/2020 Postmarket Surveillance Study Delayed
PS220001 Canary Medical, Inc. Canary Tibial Extension (CTE) w/Canary Health Implanted Reporting Processor (CHIRP) System Orthopedic 01/24/2022 Study of Subjects with the CTE Noncompliant
PS230003 Empower Medical Devices The bateman bottle General &
Plastic Surgery		 06/20/2023 Bateman Bottle Postmarket Surveillance Study Noncompliant
PS230001 Happiest Baby, Inc. Snoo smart sleeper General Hospital 03/30/2023 SNOO Smart Sleeper Study Pending
PS220002 Insulet Corporation Insulet smartadjust Clinical Chemistry 12/21/2022 SmartAdjust Technology Study Pending
PS200006 Medtronic, Inc. Carpediem Gastroenterology/
Urology		 04/29/2020 CARPEDIEM 522 Progress Inadequate
PS200004 Merit Medical Systems, Inc. Surfacer inside-out access catheter system Cardiovascular 02/10/2020 Surfacer Postmarket Surveillance Study Delayed
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Wright Redesigned/Replaced Study
PS230002 Moximed, Inc. Misha knee system Orthopedic 06/06/2023 MISHA Post-Market Clinical Study Study Pending
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database Redesigned/Replaced Study
TMJM Registry Study - Partial Redesigned/Replaced Study
Prospective Postmarket Surveillance Study Plan Progress Inadequate
Explant Analysis Study Plan Progress Adequate
PS200003 Olympus America, Inc. Evis exera iii duodenovideoscope tjf-q190v Gastroenterology/
Urology		 01/17/2020 Sampling and Culturing Study Delayed
PS210002 Pentax Pentax ed32-i10 duodenoscope Gastroenterology/
Urology		 04/01/2021 Postmarket Surveillance (PS) Study Delayed
PS190005 Pentax of America, Inc. Pentax duodenoscope model ed34-il0t2 Gastroenterology/
Urology		 11/15/2019 Sampling and Culturing Study Delayed
PS190001 Rapid-Medical, Ltd. Comaneci embolization assist device Neurology 05/22/2019 Success in Comaneci-Assist Coils Embolization Surv Delayed
PS190006 Tandem Diabetes Co. Control-iq, algorithm Clinical Chemistry 12/13/2019 Postmarket Surveillance Study Ongoing
PS200008 Tandem Diabetes Co. Control-iq technology Clinical Chemistry 06/23/2020 Postmarket Surveillance Ongoing
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis Progress Adequate
PS180002 TVA Medical, Inc. Wavelinq endoavf system Cardiovascular 06/22/2018 WavelinQ endoAVF Delayed


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources
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